A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

Trial Profile

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2018

At a glance

  • Drugs Pertuzumab (Primary) ; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Fluorouracil; Paclitaxel; Trastuzumab
  • Indications Early breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms APHINITY
  • Sponsors Roche
  • Most Recent Events

    • 20 Dec 2017 According to a Genentech media release, based on the results of this trial, the US FDA has approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence.
    • 20 Dec 2017 Results of primary analysis with a median of 45.4 months follow-up presented in a Genentech media release.
    • 09 Dec 2017 Results (n=4769) of exploratory safety analysis of diarrhoea presented at the 40th Annual San Antonio Breast Cancer Symposium
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